Package 82009-049-05
Brand: sertraline hydrochloride
Generic: sertraline hydrochloridePackage Facts
Identity
Package NDC
82009-049-05
Digits Only
8200904905
Product NDC
82009-049
Description
500 TABLET, FILM COATED in 1 BOTTLE (82009-049-05)
Marketing
Marketing Status
Brand
sertraline hydrochloride
Generic
sertraline hydrochloride
Sample Package
No
Linked Drug Pages (1)
Raw FDA Data
View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "8ebb7a30-d0c9-4604-b4ec-7fb3bba6cade", "openfda": {"unii": ["UTI8907Y6X"], "rxcui": ["312938", "312941"], "spl_set_id": ["61835f25-bfe4-49ac-9dbf-3d6387866e78"], "manufacturer_name": ["Quallent Pharmaceuticals Health LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "500 TABLET, FILM COATED in 1 BOTTLE (82009-049-05)", "package_ndc": "82009-049-05", "marketing_start_date": "20230928"}], "brand_name": "Sertraline Hydrochloride", "product_id": "82009-049_8ebb7a30-d0c9-4604-b4ec-7fb3bba6cade", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Cytochrome P450 2D6 Inhibitors [MoA]", "Serotonin Reuptake Inhibitor [EPC]", "Serotonin Uptake Inhibitors [MoA]"], "product_ndc": "82009-049", "generic_name": "Sertraline Hydrochloride", "labeler_name": "Quallent Pharmaceuticals Health LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Sertraline Hydrochloride", "active_ingredients": [{"name": "SERTRALINE HYDROCHLORIDE", "strength": "50 mg/1"}], "application_number": "ANDA077397", "marketing_category": "ANDA", "marketing_start_date": "20230928", "listing_expiration_date": "20261231"}